Minimally invasive methods for implanting a sacral stimulation lead

• US 8,781,603 B2
• Filed: 09/23/2013
• Issued: 07/15/2014
• Est. Priority Date: 07/21/2008
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Ye, Qingshan, Swoyer, John M.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/033,592
• Publication Number:
  US 20140031909A1
• Time in Patent Office: 295 Days
• Field of Search: 607116-117, 607/128, 600/377
• US Class Current: 607/117
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves

Abstract

Methods and apparatus for implanting a neural stimulation lead in a patient'"'"'s body are described. A lead assembly comprises a pointed-tip stylet, a stimulation lead, and an optional tube to deploy a fixation element attached to the lead. One embodiment of the implant methods starts with inserting the pointed-tip lead assembly directly into tissue. After the desired implant position is determined, the pointed-tip component is separated from the stimulation lead and removed from the tissue, leaving the stimulation lead implanted. After confirmation that the stimulation lead is in the right tissue location, the pointed-tip component is removed from the body, leaving the stimulation lead in place. The stimulation lead can be connected to a neurostimulator to delivery therapies to treat neural disorders, such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain, etc.

Claims

1. A stimulation lead assembly, which comprises:

a) lead, comprising;

i) an elongated, insulated lead body comprising a first length extending from a proximal lead portion to a distal lead portion having a distal lead end;

ii) at least one stimulation electrode at the distal lead portion;

iii) at least one electrical connector at the proximal lead portion;

iv) at least one conductor providing electrical continuity from the connector to the electrode; and

v) at least one fixation finger attached to an outer surface of the lead body, wherein the fixation finger is deployable to secure the lead in body tissue; and

b) an elongated lead carrier comprising;

i) a carrier sidewall extending along a longitudinal axis from a proximal carrier porion to a distal carrier portion having a distal carrier pointed-tip; and

ii) a longitudinal cavity that interrupts a portion of the carrier sidewall to provide a carrier nest for receiving the lead therein, wherein the carrier nest has a second length extending from a proximal nest portion adiacent to the proximal carrier portion to a distal nest end spaced proximally from the distal carrier pointed-tip,

iii) wherein the carrier sidewall adjacent to the carrier nest has a first annular extent about the longitudinal axis and the carrier nest has a second annular extent that when combined with the first annular extent of the carrier sidewall equals 360 degrees, and

iv) wherein the carrier distal pointed-tip extends annularly about the longitudinal axis,

c) wherein the second length of the carrier nest in longer than the first length of the lead body so that with the lead received in the carrier nest, the carrier is manipulatable is a distal direction with respect to the lead to remove the distal pointed-tip from lateral alignment with the distal lead end so that the carrier is rotatable about the longitudinal axis and with respect to the lead to thereby separate the carrier from the lead so that the carrier is further manipulatable in a proximal direction to remove the carrier from the lead without causing proximal movement of the lead.

2. The lead assembly of claim 1 wherein the fixation finger has an attached end spaced from a free end, wherein the attachment end is secured to the outer surface of the lead body and the free end is movable from a first position closely spaced to the outer surface thereof to a second, deployed position spaced from the lead body a greater distance than that of the first position.

3. The lead assembly of claim 2 further comprising a tube that is sized to slide over the proximal lead portion and along the lead body outer surface to contact the at least one fixation finger to thereby move the finger from the second, deployed position into the first position, and wherein the tube is manipulatable in a proximal direction to remove the tube from contact with the finger and thereby enable the finger to move from the first position into the second, deployed position.

4. The lead assembly of claim 1 wherein the fixation finger has a finger length that is significantly longer that either one of a finger width or a finger diameter measured along a cross-section of the fixation finger perpendicular to the finger length.

5. The lead assembly of claim 1 wherein there are at least two fixation fingers, each finger having an end secured to the outer surface of the lead body and a free end that is movable from a first position closely spaced to the outer surface thereof to a second, deployed position spaced from the lead body a greater distance than that of the first position, and wherein a first distance from the distal lead end to where the attached end of a first one of the fingers is secured to the lead body is substantially different than a second distance measured from the distal lead end to where the attached end of the second one of the fingers is secured to the lead body.

6. The lead assembly of claim 5 further comprising a tube that is sized to slide over the outer surface of the lead body to contact the at least two fixation fingers and move them from the second, deployed position to the first position closely spaced to the outer surface of the lead body, and wherein the tube includes at least two longitudinal slots of different axial depths that correspond to the different distances that the two fixation fingers attached to the lead body are spaced from the distal, lead end so that the slots simultaneously contact the fixation fingers at different distances from the distal lead end when the tube is slid over the proximal lead portion toward the distal lead end.

7. The lead assembly of claim 1 wherein there are three fixation fingers, each finger having its respective attachment end secured to the lead body at a significantly different distance measured from the distal lead end than the other two fixation fingers.

8. The lead assembly of claim 1 wherein the lead body and the at least one fixation finger are of polymeric materials that are either the same or different and are selected from the group consisting of silicone, polyurethane, and mixtures thereof.

9. The lead assembly of claim 1 wherein a hollow lumen extends along at least a portion of the length of the lead body from the proximal lead end to the distal lead portion.

10. The lead assembly of claim 9 including a pointed-tip stylet sized to be housed inside the lumen extending through the lead body.

11. The lead assembly of claim 10 wherein the stylet has a third length that is longer than the first length of the lead body so that with a proximal end of the stylet detachably secured to a proximal end of the lead, a distal end of the stylet extends out past the distal lead end.

12. A stimulation lead assembly, which comprises:

a) a lead, comprising;

i) an elongated, insulated lead body comprising a first length extending from a proximal lead portion to a distal lead portion having a distal lead end;

ii) at least one stimulation electrode at the distal lead portion;

iii) at least one electrical connector at the proximal lead portion;

iv) at least one conductor providing electrical continuity from the connector to the electrode;

v) a hollow lumen extending along the lead body from a proximal lead end to the distal lead portion; and

vi) at least two fixation fingers, each finger having an end secured to the outer surface of the lead body and a free end that is movable from a first position closely spaced to the outer surface thereof to a second, deployed position spaced from the lead body a greater distance than that of the first position, and wherein a first distance from the distal lead end to where the attached end of a first one of the fingers is secured to the lead body is substantially different than a second distance measured from the distal lead end to where the attached end of the second one of the fingers is secured to the lead body;

b) a tube that is sized to slide over the outer surface of the lead body to contact the at least two fixation fingers and move them from the second, deployed position to the first position closely spaced to the outer surface of the lead body, wherein the tube includes at least two longitudinal slots of different axial depths that correspond to the different distances that the two fixation fingers attached to the lead body are spaced from the distal lead end so that the slots simultaneously contact the fixation fingers at different distances from the distal lead end when the tube is slid over the proximal lead portion toward the distal lead end; and

c) an elongated lead carrier comprising;

i) a carrier sidewall extending along a longitudinal axis from a proximal carrier portion to a distal carrier portion having a distal carrier pointed-tip, and

ii) a longitudinal cavity that interrupts a portion of the carrier sidewall to provide a carrier nest for receiving the lead therein, wherein the carrier nest has a second length extending from a proximal nest portion adjacent to the proximal carrier portion to a distal nest end spaced proximally the distal carrier pointed-tip,

iii) wherein the carrier sidewall adjacent to the carrier nest has a first annular extent about the longitudinal axis and the carrier nest has a second annular extent that when combined with the first annular extent of the carrier sidewall equals 360 degrees, and

iv) wherein the carrier distal pointed-tip extends annularly about the longitudinal axis,

d) wherein the second length of the carrier nest is longer than the first length of the lead body so that with the lead received in the carrier nest, the carrier is manipulatable in a distal direction with respect to the lead to remove the distal pointed-tip from lateral alignment with the distal lead end so that the carrier is rotatable about the longitudinal axis and with respect to the lead to thereby separate the carrier from the lead so that the carrier is further manipulatable in a proximal direction to remove the carrier from the lead without causing proximal movement of the lead.

13. The, lead assembly of claim 12 wherein each of the at least two fixation fingers has an attached end spaced from a free end, wherein the attachment end is secured to the outer surface of the lead body and the free end is movable from a first position closely spaced to the outer surface thereof to a second, deployed position spaced from the lead body a greater distance than that of the first position.

14. The lead assembly of claim 12 wherein the at least two fixation fingers each have a length that is significantly longer than either one of a finger width or a finger diameter measured along a cross-section of the fixation finger perpendicular to the finger length.

15. The lead assembly of claim 12 wherein the tube is manipulatable in a proximal direction to remove the tube from contact with the at least two fixation fingers and thereby enable the fingers to move from the first position into the second, deployed position.

16. The lead assembly of claim 12 wherein there are three fixation fingers, each having their respective attachment ends secured to the lead body at significantly different distances measured from the distal lead end than the other two fixation fingers.

17. The lead assembly of claim 12 wherein the lead body and the at least two fixation fingers are of polymeric materials that are either the same or different and are selected from the group consisting of silicone, polyurethane, and mixtures thereof.

18. A stimulation lead assembly, which comprises:

a) a lead, comprising;

i) an elongated, insulated lead body extending from a proximal lead portion to a distal lead portion having a distal lead end;

ii) at least one stimulation electrode at the distal lead portion;

iii) at least one electrical connector at the proximal lead portion;

iv) at least one conductor providing electrical continuity from the connector to the electrode; and

v) at least one fixation finger attached to an outer surface of the lead body, wherein the fixation finger is deployable to secure the lead in body tissue; and

b) an elongated lead carrier comprising;

i) a carrier sidewall extending along a longitudinal axis from a proximal carrier portion to a distal carrier portion having a distal carrier pointed-tip; and

ii) a longitudinal cavity that interrupts a portion of the carrier sidewall to provide a carrier nest for receiving the lead therein, wherein the carrier nest extends from a proximal nest portion adjacent to the proximal carrier portion to a distal nest end spaced proximally from the distal carrier pointed-tip,

iii) wherein the carrier sidewall adjacent to the carrier nest has a first annular extent about the longitudinal axis and the carrier nest has a second annular extent that when combined with the first annular extent of the carrier sidewall equals 360 degrees, and

iv) wherein the carrier distal pointed-tip extends annularly about the longitudinal axis,

c) wherein the carrier is rotatable about the longitudinal axis and with respect to the lead to separate the carrier from the lead so that the carrier is manipulatable in a proximal direction to remove the carrier from the lead without causing proximal movement of the lead.

19. The lead assembly of claim 18 wherein there are at least two fixation fingers, each finger having an end secured to the outer surface of the lead body and a free end that is movable from a first position closely spaced to the outer surface thereof to a second, deployed position spaced from the lead body a greater distance than that of the first position, and wherein a first distance from the distal lead end to where the attached end of a first one of the fingers is secured to the lead body is substantially different than a second distance measured from the distal lead end to where the attached end of the second one of the fingers is secured to the lead body.

20. The lead assembly of claim 19 further comprising a tube that is sized to slide over the outer surface of the lead body to contact the at least two fixation fingers and move them from the second, deployed position to the first position closely spaced to the outer surface of the lead body, and wherein the tube includes at least two longitudinal slots of different axial depths that correspond to the different distances that the two fixation fingers attached to the lead body are spaced from the distal lead end so that the slots simultaneously contact the fixation fingers at different distances from the distal lead end when the tube is slid over the proximal lead portion toward the distal lead end.